BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿

    MDR report key: 17435392 · Received August 1, 2023

    Report

    Report Number
    2916837-2023-00155
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906573384
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00155 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER PHONE#: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOADER COVER WAS BROKEN AND ACCESSED BY THE USER ON THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE WAS RESOLVED VIA MAILED COVER (338709) TO CUSTOMER AND REPLACED BY CUSTOMER THEMSELVES. THE INSTRUMENT RUNS NORMALLY. FACSCANTO PLUS- THE COVER OF LOADER IS BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOADER COVER WAS BROKEN AND ACCESSED BY THE USER ON THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE WAS RESOLVED VIA MAILED COVER (338709) TO CUSTOMER AND REPLACED BY CUSTOMER THEMSELVES. THE INSTRUMENT RUNS NORMALLY. FACSCANTO PLUS- THE COVER OF LOADER IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555219 BD FACSCANTO¿ COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382906573384

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown